EMA starts rolling review of the Sputnik V COVID-19 vaccine

4 March 2021

The European Medicines Agency’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology.

The European Union applicant for this medicine is R-Pharm Germany GmbH, a subsidiary of Russia’s R-Pharm.

The CHMP’s decision to start the rolling review is based on results from laboratory studies and clinical studies in adults. These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19.

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